Recall Z-2035-2025 ยท MNS Ventilator, Continuous, Non-Life-Supporting
Philips Respironics, Inc.
BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory support for pediatric and adult patients weighing over 10 kg.
| Date | Jul 2, 2025 (initiated May 9, 2025) |
| Status | Open, Classified |
| Reason | This device does not indicate for use in patients with respiratory failure. |
| Root cause | Device Design |
| Action | Philips sent an "URGENT Medical Device Recall Notice", for All BiPAP A30 and BiPAP A40 devices, to consignees via mail 5/9/2025. Note, the letter does not address BiPAP V30 devices. The Notice informs consignees that for patients who cannot tolerate interruption or loss of therapy an alternative ventilator is required. Philips Respironics recommends that physicians and healthcare professionals assess whether the patients under their care who are using affected devices are able to tolerate interruptions to therapy. For patients who can and cannot tolerate interruptions in therapy, Philips Respi |
| Quantity | 5,958 units |
| Distribution | Worldwide distribution: US (Nationwide)including Guam and Puerto Rico; OUS (Foreign) to countries of: United Arab Emirates (AE), Argentina (AR), Austria (AT), Australia (AU), Bosnia and Herzegovina (BA), Belgium (BE), Brazil (BR), Canada (CA), Chile (CL), China (CN), Colombia (CO), Costa Rica (CR), |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.